Young woman’s death leads to questions about popular contraceptive known as YAZ

Editor’s note: This article, by Tena Starr, was first published in the Barton Chronicle.

On late Saturday afternoon, Nov. 12, when April Bapp of Brownington got a phone message from her daughter Rebecca, who didn’t feel well and was having trouble breathing. She was working that day at Community College of Vermont in Newport, and there was no one else in the building. She didn’t think she could get herself to a doctor, so her parents drove to Newport and brought her to North Country Hospital.

Six hours later Rebecca was dead. She was 21 years old.

“She couldn’t get enough oxygen in her lungs,” Mrs. Bapp said. “Her sugar was high. They weren’t sure what was going on. She was on a breathing machine, sedated, they wanted to do a CT to see what was going on, and she coded.”

The hospital had planned to Medivac her to the Dartmouth Hitchcock Medical Center in Lebanon, N.H., but Rebecca coded again. The third time, doctors couldn’t bring her back, and she died that night.

Baffled, her family asked for an autopsy. The medical examiner’s report said she died of a blood clot in her heart, April Bapp said. “And the secondary cause of death was her oral contraceptive.”

Rebecca had been taking Ocella, a relatively new and controversial type of birth control pill that is the subject of a federal advisory committee hearing this week. The prescription is also known by its popular generic brand name YAZ.

YAZ has been the suspected cause for deaths around the country, according to the Public Citizens Health Research Group.

Dr. Sidney Wolfe, director of the watchdog organization, said, “there have been a number of published studies not connected with the company that have found problems with the product.”

The organization, which Wolfe founded 40 years ago with consumer advocate and former presidential hopeful Ralph Nader, has placed YAZ on its list of “do not use” drugs.

Public Citizen’s Worst Pills, Best Pills website says that GIANVI, YASMIIN, YAZ, and ZARAH are on the “do not use” list because they can cause increased blood levels of potassium and are no more effective than other oral contraceptives in preventing pregnancy.

The federal Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee, of which Dr. Wolfe is a member, will receive a briefing on this week regarding the newest information about third-generation birth control pills, Dr. Wolfe said.

The advisory committee will examine whether the product should even be on the market, he said. New information will be available on the FDA’s website later this week. (Public Citizen sued the FDA some time ago, forcing the agency to post information on its website in a timely fashion.

For her part, April Bapp said YAZ and its relative Ocella were highly marketed products that her daughter and her doctor apparently trusted. “Those ads came across as being great and wondrous,” she said. “This is the brand they’re pushing to young girls.”

April Bapp is shocked by the sudden death of her daughter, and she is hoping that, by talking about it, she can prevent the unnecessary death of another young woman.

“If we can prevent someone else from dying, then it may help us make some sense of Rebecca’s death,” she said in a letter to the Chronicle.

“She worked at the Farm Service Agency, she worked at CCV on Saturdays, she helped out the town clerk,” April Bapp said. “She was working on her bachelor’s degree at Johnson State College. There was so much potential.”

More than 300 people attended Rebecca’s funeral.

“Everybody said how smart she was,” April Bapp said. “Rebecca’s boyfriend, they were all there on short notice for her death. It’s just not what you think is going to happen when your daughter calls and says she doesn’t feel good.”

Although April Bapp was aware that birth control pills carry health risks, her daughter’s death and the autopsy results prompted Mrs. Bapp to question the risk associated with this particular birth control pill.

YAZ, which the FDA approved in 2006, is among a newer line of birth control pills that includes other brand names such as Yasmine and Ocella. The difference between those brands and older birth control pills is that YAZ and its counterparts contain drospirenone, a progestin — basically a hormone — that is not contained in older birth control pills.

Information from the FDA is contradictory. It says that several studies have been conducted, and some indicate a higher risk for blood clots, stroke, and other problems when taking YAZ, and some do not.

“All birth control pills pose a risk of blood clots,” a September FDA website posting on the product says. “Several epidemiological studies have reported that the risk of blood clots for women who use birth control pills containing drospirenone is higher than that for women who use birth control pills containing the progestin levonorgestrel. Other studies have not reported an increase in risk.”

Levonorgestrel is the hormone in an older generation of birth control pills.

Later studies indicate an increased risk, according to the FDA, which commissioned yet another study. The results are being finalized and may be reviewed later this week by the advisory committee. Recent articles in the British Medical Journal reported a two- to three-fold greater risk of blood clots and other serious problems in women who use oral contraceptives containing drospirenone.

YAZ has been the suspected cause for deaths around the country, according to the Public Citizens Health Research Group.

An article posted on the Worst Pills website said that studies funded by the industry found lower risks of blood clots than did studies that were publicly funded. It says that drospirenone is “a close chemical cousin of spironolactone, a diuretic or water pill that causes the body to retain potassium. A 3-milligram dose of drospirenone, the amount in a daily contraceptive pill, is equivalent to 25 milligrams of spironolactone.”

A 2008 “warning” letter to Bayer HealthCare Pharmaceuticals, Inc., the company that manufactures and markets YAZ, is posted on the FDA’s website. Thomas Abrams, director of the Division of Drug Marketing, Advertising, and Communications at the U.S. Department of Health and Human Services wrote that the company was, at the time, engaged in misleading advertising practices.

“The TV ads are misleading because they broaden the drug’s indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug,” the letter says. “These violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with YAZ.”

The ads indicated that YAZ not only was an effective birth control pill, but also treated severe acne and premenstrual syndrome. Apparently, it does benefit acne problems to some extent, and also helps with premenstrual dysphoric disorder, a serious form of PMS.

The FDA warned that some of the television ads were over the top. One, called “Not Gonna Take It,” started by saying, “We all know that birth control pills are 99 percent effective and can give you shorter, lighter periods. But did you know there’s a pill that could do more?”

“It then displays images of energetic, euphoric, playful women singing ‘We’re not gonna take it’ as they kick, punch and push words describing symptoms such a irritability, moodiness, bloating, and feeling anxious away from the screen…” Abrams writes in his letter to Bayer.

He goes on to say that the product is not approved to treat severe acne or PMS, and the ads do not appropriately explain the risks involved in taking the product.

A New York Times article says that YAZ is the “go-to-selling” birth control pill in the U.S. and owes much of its popularity to a multi-million-dollar ad campaign that promotes it as a quality-of-life treatment that combats acne and severe premenstrual depression, as well as preventing pregnancy. The story goes on to say that the American unit of Bayer rigorously defends the safety of the product and says it has been extensively studied.

A New Jersey Business magazine article tells a story that resembles that of the Bapps’. It says that Michelle Pfleger, a teenager, asked for the birth control pill YAZ when she visited her doctor before going off to college. She’d seen the advertisements on television. The young woman died after a blood clot lodged in her lung while she was on her way to class at Elon University in North Carolina, the article says. Ms. Pfleger was 18.

The article says that more than 900 lawsuits have been filed in Bergen County, New Jersey , and that hundreds of other cases have been lodged in Philadelphia, California and Illinois.

Contacted Tuesday, a spokesman for Bayer did not comment except to say the company does not make Ocella.

No one from Tava, which does, responded to email.

Mrs. Bapp is doing the best she can these days.

“You try to put on a good front when you’re out,” she said. “But it’s devastating.”

Her other daughter has posted the cause of her sister’s death on Facebook in the hope of informing people.

Other contraceptives that contain drospirenone are Angeliq, Beyaz, Gianvi, Safyral, and Zarah.

Consumers may report serious problems with oral contraceptives or other products to the FDA’s MedWatch Adverse Event Reporting program at (800) FDA-1088, or www.accessdata.fda.gov/scripts/medwatch/medwatch-online.tm.

Comments

1) Advertising works – even when aimed at very intelligent, highly trained professionals such as doctors.

2) The very definition of advertising is to present a given product/view point in the best possible light, and this by definition means very important information will deliberately be left out.

3) Despite this there will be folks who call the award of punitive damages (as in telling a corporation not to engage in that activity ever again) some sort of legal lottery to be played by the lazy and shiftless (as opposed to those who actively and misleadingly marketed YAZ).

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